EU MDR Advisory Services
Obtain your CE Marking Goals Fast and Efficiently
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Our Proven EU MDR experts have worked for leading EU Notified Bodies and led New Product Development Teams in Industry!
Meet Our EU MDR Experts
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Our Proven EU MDR Experts Can Help
Clinical Evaluation Reports (CERs) / Clinical Evaluation Plans (CEPs)
With local, regional, and global capabilities, ProPharma’s team of experienced MedTech professionals support clients of all sizes to deliver CERs that meet and exceed regulatory standards.
As the world's largest RCO (Research Consulting Organization), we deliver results through an Advise | Build | Operate model to ensure data quality, reliability, regulatory compliance, and industry-leading language and writing expertise.
Years of Medical Device Engineering
Product Development Experience
Years of Employment at
Tier-1 EU Notified Bodies
Number of CERs Produced
Percentage of Successful CE Mark Certifications
Notified Bodies that we have made submission to:
BSI
DEKRA
TUV
LRQA
Click the Icons below to learn more about each topic and our services
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Accoladed and Experienced Group of EU MDR Experts
Our group of former-Notified-Body-employed experts collectively bring the benefits of over 25 years of Tier-1 EU Medical Device Notified Body work experience on a wide variety of medical devices ranging from Class III Implants in Vascular, Orthopedics, and Spine along with class III 'combination-products' aswell as class IIb devices. Our experts were selected to work at these EU Notified Bodies because of their deep product development experience on a wide variety of medical devices. Our Notified-Body-trained experts collectively also bring more than 25 years of New Product Development Engineering expertise having worked for some of the largest and most successful global medical device companies in the world.
While employed by Notified Bodies, we have collectively performed over 300?? conformity assesments - so we know, first hand, what EU Notified Bodies are looking for! In industry, our experts have cumulatively authored over 413 Clinical Evaluation Reports (CERs). Based on the cumulative career expereince of our experts, we are exceedingly well-trained and poised to handle any issue related to EU MDR submissions from, Gap Analysis, preparation for EU MDR QMS certification, mock-audit, submission preparation (partial or full), Clinical Evaluation Reoirts, Post Market Clinical Follow-Up and everything in between. Our experts are all highly acoladed engineers who are are experts in new product development with many successful product launches under their belt. It is the UNIQUE INTERSECTION of these SKILL SETS that SETS US APART. Our expertise at Pathway Med-Device Advisors International can be utilized and harnessed to proactively maximize your chances of CE Mark certification via our proactive gap analysis advisory process and submission writing services.
Feel free to get in touch with one of Pathways EU MDR experts in a convienient method of your choosing (free 30 minute consultation, text or immediate* call back - if your situtation requires urgent attention. Please feel free to contact us today to learn more about our documented track record of success with EU Notified Bodies and to discuss HOW WE CAN HELP get you and your company to the next regulatory milestone to achieve your regulatory goals with maximum urgency and efficiency.
Our team of EU Notified Body experts have performed hundreds of indepth Conformity assesments and there isn't much we haven't been exposed to or seen. We can help you and your company rapidly acheive compliance of your medical device or combination product to challenging EU MDR. We have the capability to perform deep Mock-Audit audits of your existing documentation (or we can create it from the ground up) to ensure that your device and documentation is EU MDR compliant in advance of submitting it to an EU Notified Body. We can help with specific issues or work with you and your company every step of the way from pre-clinical testing, clincal trails, risk analysis and mitigation strategies in order to prepare solid Technicql Documentation (TDs and CERs) that are EU MDR compliant. We can assit and adjust your regulatory strategy to optimize the pathway to approval for your medical device in the EU, UK, and Australia.
Pathway MDA medical device advisory servicesinclude shaping the initial regulatory stragegy for your device in preparation for a successful EU MDR submission. This is crucial to set an appropriate, efficient, yet, 'least-burdensome approaches for your regulatory strategy from Preclinical, Clinical, and Post Market Clinical Follow Up. We have experience with medical devices across all devices classes in Vascular, Neurovascular, Othropedics, spine and many other devices in a range of diagnostic and therapeutic applications. Our Industry and EU Notified Body expertise is what sets us apart from other 'consulting' firms. We are confident in our abilities and offer a 30 minute risk-free no obligation complimentary consultation.